WHO ICTRP trial
Protocol Title: The ASCEND Study: A Phase III, Multicenter, Double Blinded…
EUCTR2022-000459-35-FR · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2022-000459-35-FR |
|---|---|
| Public title | Protocol Title: The ASCEND Study: A Phase III, Multicenter, Double Blinded Vehicle Controlled Study of TMB-001 - with a Parallel Optional Maximal Use Arm - in the Treatment of RXLI (Xlinked) or ARCI Ichthyosis in Subjects Aged =6 Years |
| Scientific title | Protocol Title: The ASCEND Study: A Phase III, Multicenter, Double Blinded Vehicle Controlled Study of TMB-001 - with a Parallel Optional Maximal Use Arm - in the Treatment of RXLI (Xlinked) or ARCI Ichthyosis in Subjects Aged =6 Years - ASCEND |
| Primary sponsor | Timber Pharmaceuticals, LLC |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | Canada;Austria;United States;Italy;France;Germany;Spain |
| Conditions | Congenital ichthyosis;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] |
| Interventions | Product Name: TMB-001 ointment 0.05% Product Code: TMB-001 Pharmaceutical Form: Ointment Pharmaceutical form of the placebo: Ointment Route of administration of the placebo: Cutaneous use |
| Registration date | Jun 13, 2022 |
| Target size | 142 |
| Secondary IDs | TMB01-301;2022-000459-35-DE |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: